Omnex is an Exemplar Global certified training provider and offers this 1.5 day course under the TPECS scheme meeting the knowledge competency requirements for Medical Devices Management Systems that can be applied to all auditor grades. This seminar fully covers the ISO 13485:2016 requirements. ISO 13485 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical device sector.
Many medical device companies are utilizing ISO 13485 as a platform to build their business management systems because of its value or because third party certification is a specified requirement by customers and/or regulators.
This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.
Attendees who successfully demonstrate competence during this course will achieve a Certificate of Attainment for the following competency units:
Who Should Attend
This seminar is designed for Quality Assurance Practitioners, Managers, ISO 13485:2016 Implementation Team Members and Management Representatives.
Recommended Training and/or Experience
A general understanding of quality management systems and a minimum of 3 months of relevant experience is recommended.
Each participant will receive a seminar manual.
- Understand the application of Quality Management Principles in the context of ISO 13485:2016.
- Relate the quality management system to the organization’s medical devices, and provision of related services
- Introduction and Welcome
- Chapter 1 – Introduction to ISO 13485
- Chapter 2 – The ISO 13485 Standard Explained
- MD Written Exercise 1 (individual)
- Chapter 3 – Overview of ISO 13485:2016 Requirements
- MD Written Exercises 2a, 2b (Audit Scenarios)
- Overview of ISO 13485:2016 Requirements (cont’d)
- Breakout Exercise 2c (Audit Scenarios)
- MD Written Exercise 3 (individual)